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Regulatory status of botulinum toxins in Europe: what a buyer should check

Regulatory status of botulinum toxins in Europe: what a buyer should check

A price list tells you what exists, not what you may buy or use in your country. For botulinum toxins the regulatory question comes first. This article is a general orientation and not legal advice; your national competent authority has the final word.

Medicines, not devices

Botulinum toxins are medicinal products. In the EU they require a marketing authorisation, granted either centrally or by the national authority of the country where they are used. They are not medical devices and do not carry CE marking as medicines.

An authorisation elsewhere does not carry over

A product that is authorised in Korea, the United States or another country is not automatically authorised in the EU. A brand can be legitimate and widely used in one market and still be unavailable for lawful use in yours. Ask which authorisation applies to the exact brand and vial size you want.

Wholesale distribution

Supplying medicines wholesale in Europe is itself an authorised activity with rules on storage, transport and documentation. Ask your supplier about its authorisation and how it documents each shipment.

What our price list shows

Our price list notes that availability should be checked with your local distributor for each product. We confirm the status of any brand on request. International brands on the list are Botox (Allergan), Xeomin (Merz) and Dysport (Ipsen); the Korean brands include Botulax (Hugel), Nabota (Daewoong) and others.

Questions to ask any supplier

  • Which authorisation does this exact brand have in my country?
  • Can I see the supplier's wholesale distribution authorisation?
  • Who is the manufacturer and how are batches documented?

Related products

General information from public sources and distributor listings. It is not medical or legal advice. Always follow the instructions for use and your national regulations.

Questions about this topic?

Write to us on WhatsApp: we will confirm availability and send the manufacturer's sheet.

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